Regulatory Strategy & Submissions

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Regulatory Strategy & Submissions


Whether this is the first or tenth product you have brought to market, careful preparation for each milestone and possible challenge is necessary or your entire development and marketing strategy could be derailed. Planning is key to this process, and knowledge of each regulatory agency’s intricacies is a major plus.

Our client base spans across more than 45 countries, and over the last 36 years we have helped countless companies achieve successful interactions with both the FDA and EMA.  Regardless of where you’re located or what agency you’re seeking approval from, our experts can help get you where you need to be, setting your product up for success.  In conjunction with our sister company, Southwood Research, and regulatory experts in our parent company ProPharma Group’s offices in the Netherlands, Sweden, and Germany, The Weinberg Group can help with any and all of your FDA and EMA needs.

FDA Regulatory Strategies & Submissions

Whether you need help executing your entire regulatory strategy, producing an FDA briefing package, or conducting a Pre-IND Meeting, The Weinberg Group’s experience and positive working relationship with the FDA means we will get the job done right. We work with you to do what is necessary to move to the next milestone.

Our Project-Based Regulatory Strategy and Submission Services Include:

Your goal is to get your product approved and on the market in the most efficient way possible.  To make this happen, we ensure you have a solid and effective regulatory strategy.

Learn more about our Regulatory Strategy services.

Pre-IND Meeting
  • To the best extent possible, any meeting with the FDA should end in clarity.  During the Pre-IND Meeting Sponsors have the chance to discuss the requirements for opening an IND with the Agency.
End of Phase 2 Meeting
  • During this meeting, you need to effectively present your Phase 3 and submission strategy and ensure that you are aligned with the FDA prior to the start of Phase 3.
Pre-NDA Meeting
  • When you leave your Pre-NDA Meeting, you should have an understanding of the FDA’s expectation for content. It is important to have clarity and shared expectations.
  • During the Pre-NDA Meeting, you must make the most of the opportunity to solicit comments and clarification from the FDA on the acceptability of:
    • Pivotal clinical data, including late-breaking data that might become available for submission during the FDA’s review of the NDA
    • CMC information and, in particular, the extent of stability data
    • Content of the ISE and ISS sections
FDA Advisory Committee Meetings
  • Each Advisory Committee is different and has specific needs and concerns, and you must keep these in mind as you discuss your product.
  • Understand how the committee will view your product, their likely issues, and area of focus must be planned for and analyzed.
Learn more about our FDA Meeting Services

IND Submission
  • The sooner you can begin your clinical trials, the sooner your product will be on the market, and in order to prevent any hiccups in this process, your final IND submission must be error free and contain all of the required information.
NDA Submission: 505(b)(1) and 505(b)(2) Assistance
  • As you can imagine, this type of submission requires extensive research, including both clinical and nonclinical studies to prove the product’s safety and efficacy for the indication being sought.
Orphan Designation
  • Obtaining orphan designation can be a challenging task, especially when the designation on its own isn’t enough. We can help you determine if your product is eligible for orphan status and, if it is, we can assist you through the process of preparing and submitting the Orphan Drug Designation application to FDA.
ANDA Submission
  • Nearly 90% of ANDAs are not accepted by the FDA for review on the first pass. We have the knowledge and expertise you need to increase your chances of beating the odds, saving you both time and resources.
  • Once the ANDA has been accepted for review, then the product review process must start. This requires technical knowledge and experience.  We can help throughout this process.
Learn more about our FDA Submission Services

Study Design, Placement, & Monitoring
  • Nonclinical study design, placement, and monitoring are critical components of nonclinical drug development and are conducted before and after a lead candidate has been selected. The Weinberg Group’s team of experts can work with you along the way to ensure it is done correctly the first time.
Discovery Stage Assistance
  • Discovery (or exploratory) toxicology provides essential early safety information that helps Sponsors distinguish key characteristics of potential lead molecules. Our experts are well versed in the data that needs to be presented to FDA and are waiting to assist you with the design, evaluation, and optimization of your investigative toxicity and exploratory/discovery studies.
Results Analysis & Design of Follow-On Work
  • From the interpretation of data from nonclinical studies to updating and modifying report templates and recommending follow-up/supplemental studies, our experts have the knowledge and experience needed to ensure the success of your nonclinical drug development program.
Learn more about our Nonclinical Drug Development Services

When you are considering the acquisition of a new product or company, it is of the utmost importance that you are sure that all parts are in good working order and that no surprises are uncovered after the purchase is complete.

Learn more about our Regulatory Due Diligence Services

 

EMA Regulatory Strategies & Submissions

Through our sister company, Southwood Research, we are excited to announce that we now have complete pre- and post-authorisation capabilities in the European Union.

Our EMA Regulatory Strategy and Submission Services Include:

Regulatory Strategy
  • Whether you’re working on a national, European, or global level, we can help you develop an appropriate regulatory strategy from early development through product maintenance or anywhere in between. Specifically, some of the services we offer include:
    • Gap analysis of existing or new dossiers
    • Draft and coordinate the Regulatory Product Development Plan, covering all aspects of development
    • Advise on regulatory deliverables and timelines
    • Advise on interactions with Healthy Authority (HA)
    • Advise on filing strategy (i.e., legal basis for application, choice of procedure, etc.)
Regulatory Deliverables
  • Pre-authorisation regulatory deliverables are a critical part of the regulatory approval process. We can help you develop and submit the best possible deliverables for submission to the EMA, working with you to successfully move your product through the development lifecycle.  These deliverables include:
    • Orphan drug designation
    • Paediatric Investigational Plan (PIP)
    • PRIME eligibility request
    • Scientific advice briefing book
Medical/Technical Writing
  • Preparing to submit an application to the EMA can be overwhelming and stressful. We are here to help make the entire process as smooth and efficient as possible. As such, we can assist with your Investigational Medicinal Product Dossier (IMPD) and Marketing Authorisation Application (MAA) submissions by reviewing and/or authoring the following:
    • IMPD and Investigator’s Brochure (IB) submissions
    • Preclinical and clinical study protocols
    • Module 2, including Quality overall summary, Nonclinical Overview and Summary, and Clinical Overview and Summary
    • Module 3 Quality, including drug substance and product sections
    • Modules 4 and 5
    • Risk Management Plans (RMP)
    • Environmental Risk Assessment (ERA) for GMOs
Scientific Advice & Pre-Submission Meetings
  • As you prepare your submission, a Sponsor can seek scientific in one of two ways: (1) at a national level from their individual member states regulatory authorities, or (2) from the EMA’s CHMP. The requirements for obtaining scientific advice varies based on the type you are seeking and may or may not require a face-to face meeting to discuss the advice being provided.  Navigating the rules and regulations for each type of advice can be challenging, but we have the knowledge and experience to help you obtain the best information that will ultimately help you obtain marketing authorization (MA).
  • Although scientific advice is not a requirement for approval, it is important to note that MAA approval rates are much high for companies who seek the agency’s advice and follow it.
  • Our specific scientific advice services include:
    • Lead development of briefing book package
    • Prepare briefing documents and submission of briefing book package
    • Prepare and submit responses to questions
    • Conduct rehearsals prior to attending HA meetings
    • Lead HA meetings
EMA Submissions
  • Preparing and submitting your application to the EMA is the final step to receiving marketing authorization (MA) for your product. Making sure it is done the right way the first time around will save you a significant amount of resources and will help get your product on the market faster. We can help you do exactly that.  In order to make this process as smooth as possible, we offer the following assistance:
    • Manage dossier compilation for HA submissions
    • Prepare Module 1, regional administrative documents
    • Prepare submission in accordance with eCTD
    • Prepare and submit responses to questions

Although your product has been approved by the EMA and is now on the market, your work with the Agency is far from over.  We are here to help make sure all of the post-authorisation requirements are completed in a compliant manner and in accordance with all EMA timelines.

Product Launch
  • You have obtained approval of your product and are ready to begin marketing it in the EU. As you have probably heard, first impressions are everything, so this is a big time for your company and product.  Making sure you have an airtight strategy and plan in place and are compliant with all EU and local regulatory legislation updates is critical.  Our team of experts has the experience and expertise to help facilitate these activities and make sure you are in the best spot possible when your product finally reaches the market.
Line Extensions (LE) & Variations
  • Whether it is an LE with completely new formulations or new variations of the same formulation (i.e., new indications, dose level, large CMC variation, etc.), we can help you successfully navigate the process in the following ways:
    • Develop regulatory strategy
    • Prepare and submit actual submission package(s)
    • Act as the primary point of contact with the HA
Product Information (PI)
  • Even though your product has already been approved, it is still critical that your Core Data Sheet, summary of product characteristics (SmPC), patient leaflet (PIL), and labeling stay up-to-date. There are a number of PI requirements that extend well past MA and we can help ensure you meet all of them.  Specifically, we can assist with:
    • Development of Core Data Sheet
    • Development of local labels/harmonisation text
    • Readability testing
    • Translations
    • Implement PI changes
Post-Authorisation Commitments
  • From post-authorisation safety and efficacy studies and drug utilization studies to educational materials, there are still a number of requirements you must meet after your product obtains MA. We can help make sure you stay on top of all these post-authorisation commitments by helping with:
    • Protocol and report review
    • Review of annual progress reports
    • Submission of progress reports and final outcome commitments
Pharmacovigilance
  • Good pharmacovigilance practices (GVP) are a set of rules designed to facilitate the execution of pharmacovigilance within the EU. These rules apply to all MA holders and are enforced by the EMA as well as local regulatory authorities within the EU member states.  We can help make sure you are compliant with all applicable GVPs by working with you to develop a risk management plan (RMP) as well as periodic safety update report (PSUR).
  • Specifically, we can help in the following ways:
    • Update RMP, as necessary
    • Track RMP commitments
    • Contribute to core PSUR and write region-specific appendices
License Renewal
  • In the EU, an MA is valid for a period of one to five years depending on the circumstances under which the application was approved. After that, the marketing authorization holder (MAH) may apply for renewal of the license.  We can help you determine when you need to renew your license and can assist throughout the entire process, preparing and submitting the renewal package and responding to questions from the agency as they arise.
Compliance
  • After your product has received MA from the EMA and is on the market, there are a number of additional compliance requirements that must be met by the MAH. We can help you navigate the entire post-authorisation landscape ensuring that you are compliant with all applicable regulations.  We can assist with the following post-authorisation compliance activities:
    • Control of promotional material versus (inter)national code of conduct
    • Data migration
    • SOP writing

 

The Weinberg Group:  FDA & EMA Regulatory Experts

Are you in the process of developing an FDA- or EMA-regulated product?  Are you seeking regulatory approval to market your product in the US or the EU?  Have you already obtained marketing approval for your product and are seeking to ensure you are compliant with all post-approval requirements and regulations? Regardless of where you are in the development and approval lifecycle, we can help you achieve successful interactions with the applicable regulatory agency(ies).

Contact us today to learn more about our service and how we can help you.